ARCHIVED — Vol. 145, No. 26 — December 21, 2011

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Registration

SOR/2011-279 December 2, 2011

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1609 — Talc)

P.C. 2011-1387 December 1, 2011

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1609 — Talc).

REGULATIONS AMENDING THE FOOD
AND DRUG
REGULATIONS (1609 — TALC)

AMENDMENT

1. The portion of subitem T.1(1) of Table VIII to section B.16.100 of the Food and Drug Regulations (see footnote 1) in column II is replaced by the following:

The portion of subitem T.1(1) of Table VIII to section B.16.100 of the Food and Drug Regulations (see footnote 1) in column II is replaced by the following:

Item No.

Column II
Permitted in or Upon

T.1

(1) Dried split legumes; Rice

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issue and objectives

The Food and Drug Regulations (“the Regulations”) regulate the sale and use of food additives in Canada, listing the permitted food additives and how they may be used. Health Canada has received a submission from industry requesting that the Regulations be amended to enable the use of talc as a coating agent in the production of dried split peas, soybeans and fava beans at a maximum level of use consistent with good manufacturing practice.

The evaluation of available data supports the safety and effectiveness of this food additive in the above specified use. Since there are no safety concerns regarding the use of this food additive on dried split legumes, the Regulations are amended to permit the extended use of talc on dried split legumes at a maximum level of use consistent with good manufacturing practice. This amendment reduces the regulatory burden to both government and industry.

This amendment benefits consumers by allowing greater availability of food products in the marketplace while continuing to help protect their health and safety. In addition, this amendment benefits industry by facilitating the manufacture of food products.

Description and rationale

This amendment to the Regulations enables the use of the food additive talc as a coating agent in the production of free flowing dried split legumes at a maximum level of use consistent with good manufacturing practice.

There is no anticipated increase in cost to government from the administration of this amendment to the Regulations. The use of food additives is optional and therefore a manufacturer choosing to use a food additive in its products voluntarily assumes the costs associated with its use and compliance with the Regulations.

An Interim Marketing Authorization (“IMA”) was issued to permit the immediate use of this food additive as proposed in the submission while the regulatory process was undertaken to amend the Regulations. The IMA was published in the Government notices section of the Canada Gazette, Part Ⅰ, on September 27, 2008, for the use of talc as a coating agent on dried split peas, soybeans and fava beans, at a maximum level of use consistent with good manufacturing practice. The IMA expired on September 27, 2010. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of the IMA remain valid.

The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the use described above for this food additive. Based on the additive’s safety and efficacy assessment and the history of safe use of talc in the production of dried split peas, soybeans and fava beans since the issuance of the IMA, the Minister is recommending to amend the Regulations to enable the use of this food additive.

Consultation

Health Canada has announced the publication of the IMA for this food additive through posting on its Web site. Health Canada also notified World Trade Organization members about this IMA and the proposed regulatory amendments at the time of publication of the IMA in the Canada Gazette, Part Ⅰ. These publications were followed by a 75-day comment period. Since this food additive has a long history of safe use as a permitted food additive in Canada in other food products, no input regarding its broader use on dried split legumes was needed or sought.

Implementation, enforcement and service standards

The Canadian Food Inspection Agency (“CFIA”) is responsible for the enforcement of the Food and Drugs Act and the Regulations with respect to foods. The CFIA uses a science-based risk management approach to set its food safety priorities. Using this approach as its foundation, the CFIA plans its inspection and testing programs for foods, taking into account the degree of risk associated with a particular sector and concentrates its resources where risk is the greatest. Each CFIA commodity inspection program performs ingredient verifications at which time inspectors compare formulation and list of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the compliance history in relation to the manufacturing of a particular type of product, the compliance history of the manufacturer and the food safety risk.